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上海醫藥(601607.SH):SPH6516片開展晚期惡性實體瘤的臨牀試驗獲批
格隆匯 08-31 17:08

格隆匯8月31日丨上海醫藥(601607.SH)公佈,公司開發的SPH6516 (SPH6516片”或項目)收到國家藥品監督管理局(“國家藥監局”)核准簽發的《藥物臨牀試驗批准通知書》,將於近期啟動國內I期臨牀試驗

結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,SPH6516 片符合藥品註冊的有關要求,同意本品開展晚期惡性實體瘤的臨牀試驗。

SPH6516具有廣譜的抗腫瘤作用用於晚期實體瘤的治療。具有激酶抑制活性高、腫瘤細胞增殖抑制活性好、體內抑瘤藥效強以及聯合用藥增效明顯等優點

項目由上海醫藥集團股份有限公司自主研發,上海醫藥集團股份有限公司擁有完全知識產權。項目2019 7月啟動立項,202012月完成臨牀前研究, 並於20216獲得國家藥監局正式受理(詳見公司公吿臨 2021-060 號)近日,該項目獲得了國家藥監局核准簽發的《藥物臨牀試驗批准通知書》,同意按照已提交的方案開展新藥臨牀試驗。

截至目前,該項目已累計投入研發費用為2818.05萬元人民幣。

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